Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in COPD Patients

January 31, 2020 updated by: Bilel Tounsi, Faculty of Medicine, Sousse

Effect of Inspiratory Muscle Training During PR on Dyspnoea and Exercise Tolerance in Chronic Obstructive (COPD)

Chronic obstructive pulmonary disease is a respiratory disease that results in progressive airflow limitation and respiratory distress.

The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme is uncertain. The investigators aimed to demonstrate that, in patients with obstructive pulmonary disease, IMT performed during a PRP is associated with an improvement of dyspnoea and exercise tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the effect of the inspiratory muscle training (with incremental load every two weeks in two months) performed during pulmonary rehabilitation on dyspnoea, 6 minutes walk test and quality of life using the St George's respiratory questionnaire (SGRQ) in COPD patients.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4002
        • Bilel TOUNSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Were COPD diagnosed by pulmonary function testing
  • Clinically stable
  • Abscence of other obstructive diseases
  • Signed written consert

Exclusion Criteria:

  • Were previous pneumonectomy or lobectomy in the past 6 months
  • spontaneous risk of pneumothorax or rib fracture
  • Incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
  • The absence of written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
aerobic exercice
Other: Pulmonary rehabilitation
The Active Comparator group received only aerobic exercise.
Experimental: IMT goup
Inspiratory muscle training + aerobic exercice
Other: Pulmonary rehabilitation+IMT
The experimental group receives inspiratory muscle training and aerobic exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnoea
Time Frame: Baseline, After 2 months
The dyspnoea were measured before and after the 6 minutes walk test
Baseline, After 2 months
Inspiratory muscle strength
Time Frame: Baseline, After 2 months
The inspiratory muscle strength were measured by maximal inspiratory pressure test
Baseline, After 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 6, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPD-DYS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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